Software-Enhanced Drugs: How They’re Redefining Patient Care

The pharmaceutical industry is positioned to undergo a significant transformation with the rise of software-enhanced (SE) drugs. This innovative approach is not only revolutionizing patient care but also opening new pipelines of opportunity for forward-looking industry leaders.

From left to right: David Klein, Click Therapeutics Founder & CEO, Anthony Costello, Medidata CEO, Tony McDermott, Click Therapeutics VP of Global Commercial Strategy, Shaheen Lakhan, Click Therapeutics Chief Medical Officer, and Lisa Moneymaker, Medidata Chief Strategy Officer discuss the future of patient care and software-enhanced drugs.

Recently, Medidata and Click Therapeutics brought together a panel of industry experts to discuss why now’s the time for pharmaceutical companies to embrace SE drugs. Read on for key takeaways from the group discussion.

1. The Time for Software-enhanced Drugs is Now

The confluence of technological advancements, evolving regulations (like the FDA's Prescription Drug Use-Related Software draft guidance), and the rapid progress in AI has created a fertile ground for software-enhanced drugs.

“It's been really clear now since the first development of digital therapeutics that software can drive clinical outcomes in diseases. That's something that's pretty broadly accepted now.”

– David Klein, Click Therapeutics Founder and CEO

It’s now understood that software can drive clinically meaningful outcomes in various diseases, going beyond simple companion apps to truly integrated solutions that enhance drug efficacy.

2. Demonstrating Clinical Benefit and Label Expansion

A key differentiator for software-enhanced drugs is their ability to demonstrate additional clinically-meaningful benefits that can be incorporated directly into a drug label. Anthony Costello, Medidata's CEO, emphasized this point, saying, "The app shows clinical benefit, the drug shows clinical benefit, but the real vision behind the Prescription Drug Use guidance is that these two things in combination are better than either one independently. So you're really getting a true 1 + 1 = 3 benefit in the label." This means that the combination of a drug and its software counterpart can be better than either one independently. This is a game-changer for pharmaceutical companies, offering a competitive advantage and the potential for label expansion.

3. Broad Applicability Across Therapeutic Areas

While the immediate benefits for cognitive-based disease states might seem obvious, software-enhanced drugs have applicability across a wide range of therapeutic areas. David Klein highlighted this by explaining that it can be applied to "really any disease with an underlying neurological or behavioral component... almost every disease has a component like that." This includes oncology, dermatology, and the GLP-1 space, where behavioral interventions are often already prescribed as adjuncts to medication. Any disease with an underlying neurological or behavioral component can potentially benefit from a software-enhanced approach.

4. The Power of Real-world Data and Patient Engagement

Software-enhanced drugs allow for the continuous collection of rich, real-world data in real-time, including physiological, behavioral, and contextual information.

“With the digital therapeutic that's constantly on board with the patient... we're able to capture more real-time data on that patient, and if there's the need for the HCP to intervene in therapy, they have that opportunity to see that data.”

– Tony McDermott, Click Therapeutics' Vice President of Global Commercial Strategy

This data can be used to refine products, optimize treatment regimens, and facilitate timely interventions by healthcare providers. These digital therapeutics are also designed to be patient-friendly and engaging, fostering a strong "digital working alliance" that drives better adherence and long-term sustainability of the product.

5. Strategic Partnerships and Accelerated Development

The partnership between companies like Medidata and Click Therapeutics highlights the importance of collaboration in this evolving landscape. Anthony Costello remarked on this synergy, stating, "You've got to have the innovative app, you've got to have the clinical trial process, you've got to have global reach... can we work together to plug these new digital therapeutics straight into a clinical trial process and come out the other side as fast as possible?" Such partnerships aim to accelerate the clinical development process for software-enhanced drugs, leveraging expertise in both innovative app development and efficient clinical trial execution. They help pharmaceutical companies navigate regulatory complexities, standardize processes, and achieve global reach, turning this innovation into a competitive race.

6. Addressing Industry Challenges and Future Outlook

Software-enhanced drugs offer solutions to several issues faced by the pharmaceutical industry, including simplifying complex treatment regimens, enhancing patient identification in rare diseases, and providing a unique value proposition in increasingly competitive therapeutic areas. Tony McDermott pointed out, "For products that are around let's say 3 to 5 years from patent expiry, what can they do to increase that runway of the product and the uniqueness of that product?".

Looking ahead, experts envision a future where software-enhanced drugs are standard in clinical development, driving a paradigm shift towards value-based care models and fundamentally transforming the patient experience.

Dr. Shaheen Lakhan, Chief Medical Officer for Click Therapeutics, summarized the core scientific approach: "These are digital medicines that are intentionally designed to hit mechanisms... that work across the whole domains of human experience much like molecules work on receptors and targets and have an action."

Software-enhanced drugs represent a significant leap forward in medicine, promising better patient experiences, improved outcomes, and new avenues for growth and differentiation within pharmaceutical pipelines. The clear regulatory pathways, combined with continuous technological advancements, ensure that this is not just a promise but a current reality with immense potential.

Find out how your organization can get started with Software-Enhanced drugs. Schedule a meeting now.